You might be thinking, that’s an odd title: obviously FDA’s breakthrough device designation is helpful.  However, after looking at the data, my conclusion is that I would avoid the breakthrough device designation for any product that qualifies for the 510(k) process.  The process is likely not helpful for such devices.

[Update – August 3, 2022: See the bottom of this post.]

Continue Reading Unpacking Averages: Assessing Whether FDA’s Breakthrough Device Designation Is Helpful